evinacumab

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Generic Name:
evinacumab
Project Status:
Complete
Therapeutic Area:
Homozygous familial hypercholesterolemia (HoFH)
Manufacturer:
Ultragenyx Pharmaceutical Inc.
Call for patient/clinician input open:
Brand Name:
Evkeeza
Project Line:
Reimbursement Review
Project Number:
SR0778-000
Call for patient/clinician input closed:
NOC Status at Filing:
Pre NOC
Performance Metric:
Achieved
Biosimilar:
No
Manufacturer Requested Reimbursement Criteria1:
Ultragenyx is requesting evinacumab be reimbursed as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients aged 5 years and older with homozygous familial hypercholesterolemia (HoFH).
Submission Type:
Initial
Fee Schedule:
Schedule E
Indications:
​evinacumab is indicated as an adjunct to diet and other low-density lipoprotein cholesterol (LDL-C) lowering therapies for the treatment of adult and pediatric patients aged 5 years and older with homozygous familial hypercholesterolemia (HoFH).
Recommendation Type:
Reimburse with clinical criteria and/or conditions
Final Recommendation:
  1. The requested reimbursement criteria are provided by the applicant and do not necessarily reflect the views of Canada's Drug Agency. Reimbursement criteria from Canada's Drug Agency will be documented in the final recommendation, if applicable.
Key Milestones2
Call for patient/clinician input openMarch 16, 2023
Call for patient/clinician input closedMay 09, 2023
Clarification:

- Patient input submission received from the Canadian Organization for Rare Disorders and Canadian Heart Patient Alliance

Submission receivedMay 10, 2023
Submission acceptedMay 25, 2023
Review initiatedMay 26, 2023
Draft CADTH review report(s) provided to sponsor for commentAugust 10, 2023
Deadline for sponsors commentsAugust 21, 2023
CADTH review report(s) and responses to comments provided to sponsorSeptember 15, 2023
Expert committee meeting (initial)September 27, 2023
Draft recommendation issued to sponsorOctober 11, 2023
Draft recommendation posted for stakeholder feedbackOctober 19, 2023
End of feedback periodNovember 02, 2023
Clarification:

- Reconsideration: minor revisions requested by drug programs

- Request for reconsideration accepted

Final recommendation postedJanuary 31, 2024
Deadline for sponsor to submit redaction requests on draft CADTH review report(s)January 29, 2024
CADTH review report(s) postedApril 17, 2024